US False Claims Act Investigations of Unnecessary Percutaneous Coronary Interventions

Abstract

This case-control study assess the association of US False Claims Act investigations of the overuse of PCIs with PCI volumes.

The US False Claims Act allows individuals to sue government contractors if they have private knowledge that the contractors defrauded the government. The act was originally intended to combat fraud by defense contractors. Recently, several physicians, hospitals, and other health care clinicians have been penalized under the act for billing Medicare for unnecessary care.¹ In this study, we sought to identify US False Claims Act investigations of the overuse of percutaneous coronary interventions and assess their association with percutaneous coronary intervention (PCI) volumes.

Methods

We identified PCI-related US False Claims Act cases by searching US Department of Justice press releases for announcements with the terms stent, cardiovascular, angioplasty, or percutaneous coronary intervention. Additionally, we searched the NewsBank news database (NewsBank, Inc) to identify unresolved cases. This study was deemed exempt from human participants review by the Emory University institutional review board.

We identified 16 hospitals that were investigated for performing unnecessary PCIs. We measured PCI volumes at the 8 hospitals located in states for which we had inpatient and ambulatory surgery data (Florida, Kentucky, Maryland, and New Jersey). Cases against these hospitals became public in 2007, 2008 (2 hospitals [12.5%]), 2010 (3 [18.8%]), 2011, and 2015. We measured PCIs using all-payer outpatient and inpatient hospital data for the period from January 2006 to December 2017.²

We identified PCIs using Current Procedural Terminology codes on outpatient records and International Classification of Diseases, Ninth Revision (ICD-9 ) and ICD Tenth Revision (ICD-10) codes on inpatient records. We excluded patients with a diagnosis code for acute myocardial infarction (AMI). We matched each investigated hospital without replacement to another hospital in the same state on the basis of 2006 non-AMI PCI volumes. We used t tests to assess the significance of differences between 2006 and 2017. We used a linear regression with robust standard errors on aggregate data to test the equivalence of time trends between investigated and matched, noninvestigated hospitals. Analyses were performed using Stata, version 16 (StataCorp), and an α of 5% was used for significance testing.

Results

We identified 16 cases in which hospitals were investigated under the False Claims Act for billing Medicare for unnecessary PCIs (Table). Fourteen (87.5%) have been resolved with a settlement. In 3 of the 16 cases (18.8%), the US Department of Justice also successfully sought prison terms for individual cardiologists. Most of the investigated hospitals were in the Midwest, South, or mid-Atlantic regions.

Table. Hospitals and Cardiologists Accused of Billing Medicare for Unnecessary PCIs^a.

Defendant	State	Periodb	Resolutionc
Lawnwood Regional Medical Center & Heart Institute/Regional Medical Center Bayonet Point	Florida	Unspecified	Case pending
Fairview Park Hospital	Georgia	2008-2009	Settled for $2 million
Joseph P. Galichia/Galichia Medical Group	Kansas	2008-2014	Settled for $5.8 million
St Joseph Health System	Kentucky	2007-2012	Settled for $16.5 million; physician sentenced to serve 30 mo in prison
King’s Daughters Medical Center	Kentucky	2006-2011	Settled for $40.9 million; physician sentenced to serve 5 y in prison
Peninsula Regional Medical Center	Maryland	2003-2006	Settled for $1.8 million; physician sentenced to serve 8 y in prison
MedStar Health Inc	Maryland	2006-2011	Settled for $35 million
St Joseph Medical Center	Maryland	2008-2009	Settled for $22 million
Detroit Medical Center	Michigan	Unspecified	Case pending
St Michael’s Medical Center	New Jersey	2009-2015	Settled for $450 000
EMH Regional Medical Center	Ohio	2001-2006	Settled for $3 863 857
North Ohio Heart Center Inc	Ohio	2001-2006	Settled for $541 870
University of Pennsylvania Health System; physician settled for $126 617	Pennsylvania	2008-2012	Settled after voluntary disclosure for $845 000
Aria Health Systems	Pennsylvania	2012-2014	Settled after voluntary disclosure for $564 700
Medicor Associates/Hamot Medical Center (now UPMC Hamot)	Pennsylvania	2004-2010	Claims withdrawn (but $20.75 million settlement over alleged violations of anti–kickback and self-referral laws)
Jackson-Madison County General Hospital	Tennessee	2004-2011	Settled for $1 328 465; physician settled for $1.15 million

Abbreviation: PCI, percutaneous coronary intervention.

^aWe identified PCI-related US False Claims Act cases by searching US Department of Justice press releases for stent, cardiovascular, angioplasty, or percutaneous coronary intervention. Additionally, we searched the NewsBank news database (NewsBank, Inc) to identify unresolved cases.

^bThe period over which unnecessary care is alleged to have occurred.

^cThe terms of resolution do not include provisions in corporate integrity agreements, judgements or settlements in related malpractice cases or other legal actions, or sanctions by state medical boards.

There were 676 729 PCIs in patients without an AMI in Florida, Kentucky, Maryland, and New Jersey during the study period. There were 234 hospitals in these 4 states that performed at least 25 PCIs in patients without AMI over the study period. Of these, 8 (3.4%) had cases that became public during the study period. In 2006, investigated hospitals accounted for 11 520 of 85 454 PCIs (13.5%) in patients without an AMI in these states.

The Figure shows trends in mean hospital-level PCI volumes. In the 8 investigated hospitals, the mean (SD) annual PCI volume of patients without an AMI declined from 1440 (686) procedures in 2006 to 271 (120) procedures in 2017 (81.2%; P < .001). The total number of procedures in these hospitals declined from 11 520 to 2172. Among matched, noninvestigated hospitals, the mean (SD) volume declined from 1168 (620) to 369 (235) procedures (68.4%; P = .003). An F test eliminated the null hypothesis of equal trends between groups (F = 20.73; P < .001).

Figure. Trends in Annual Mean Percutaneous Coronary Intervention (PCI) Volume in Patients Without Acute Myocardial Infarction (AMI), Investigated Hospitals, and Matched Noninvestigated Hospitals.

The 8 investigated hospitals were matched without replacement to another hospital in the same state on the basis of 2006 PCI volume (in patients with and without AMI).

^aDate at which the investigation of 1 hospital went public.

^bDate at which the investigation of 2 hospitals went public.

^cDate at which the investigation of 3 hospitals went public.

Conclusions

Physicians and hospitals that bill Medicare for unnecessary PCIs risk investigation under the US False Claims Act, especially if potential penalties are large based on high procedure volumes. When prosecuting individual cardiologists, the US Department of Justice often introduced evidence that cardiologists overstated the degree of stenosis in patients to show that they knowingly delivered unnecessary care. Depending on how common this practice is, estimates of the share of PCIs that are rarely appropriate based on appropriate use criteria³ are likely underestimated.

It is difficult to precisely identify the association of the investigations with PCI use. Declines in procedure volumes at each hospital that was investigated generally coincide with the initiation of the investigations. However, volumes probably would have declined in the absence of the investigations as a result of the 2007 COURAGE trial.⁴ The investigations may have led physicians at noninvestigated hospitals to adopt more conservative practice styles, as was the case with the US Department of Justice’s investigation into implantable cardioverter defibrillators placed outside of Medicare coverage guidelines.⁵